SOURCE: International Stem Cell Corporation

International Stem Cell Corporation

November 04, 2014 08:30 ET

FDA Clears ISCO's Stem Cell Line for Clinical Uses

CARLSBAD, CA--(Marketwired - November 04, 2014) - International Stem Cell Corporation (OTCQB: ISCO), a California-based biotechnology company developing novel stem cell based therapies and biomedical products, today announced that the U. S. Food and Drug Administration (FDA) has cleared ISCO's human parthenogenetic stem cells line for investigational clinical use.

"Many stem cell lines can never be used to develop commercial therapeutic products because they don't meet the FDA's ethical and quality standards. With this clearance from the FDA, based on the safety of our cells and quality of our manufacturing processes, the Company has removed any uncertainty in the potential clinical use of human parthenogenetic stem cells," said Dr. Ruslan Semechkin, ISCO's Chief Scientific Officer. "Not only does this increase the chance that our regulatory submission for the treatment of Parkinson's disease, which we will be submitting before the end of the year, will be approved, but it also means that our human parthenogenetic stem cells can serve as the basis for investigational clinical studies for other indications, for example stroke or traumatic brain injury."

To be approved by the FDA for use in human trials and commercial therapeutic products, stem cells must be grown under what's known as good manufacturing practice (GMP) conditions. GMP standards require that each batch of cells is grown in identical, repeatable conditions, ensuring that they have the same properties, and each person receiving a stem cell therapy would be getting an equivalent treatment. Achieving this level of consistency is difficult and requires knowing the exact identity and quantity of every component of the media that the cells grow in and characterizing cell batches extremely precisely, as well as rigorous quality control and assurance. 

ISCO will use its own GMP facilities in Oceanside CA to produce the cells in preparation for the first clinical trial. An update on the status of the manufacturing of the first batch of clinical-grade human parthenogenetic neural stem cells will be provided in the near future.

The FDA also requires that the original tissue donation and every component used to produce the final product are derived using the Good Tissue Practice (GTP) regulations. GTP is primarily designed to reduce the risk of an infectious disease being transmitted via a live human cell transplant. ISCO provided evidence to the FDA in the form of an evaluation of the original egg donor's risk of communicable infectious diseases, the testing of the master cell bank for a number of infectious agents including HIV and HBV and the genetic stability of the stem cell line.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com and companyblog.intlstemcell.com.

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Forward-looking Statements

Statements pertaining to anticipated developments, the expected timing and results of preclinical and clinical studies and subsequent regulatory filings, the potential benefits of research programs and products, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

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Contact Information

  • Contacts:
    International Stem Cell Corporation
    Dr. Simon Craw
    Executive Vice President
    Phone: 760-940-6383
    Email: ir@intlstemcell.com